(155 days)
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470nm Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The Multiwavelength laser is further indicated for laser assisted lipolysis.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat
- Excision and vaporization of vocal cord nodules and polyps
- Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx
- Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II
- Neck dissection
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy
- Synovectomy
- Chondromalacia
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding
- Excision and vaporization of colorectal carcinoma
- Excision of polyps
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids
- Liver resection
- Excision of cutaneous lesions
- Hemorrhoidectomy
- Appendectomy
- Debridement of decubitus ulcers
- Hepatobiliary tumors
- Mastectomy
- Dermabrasion
- Vaporization and hemostasis of capillary hemangioma
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy
- Herniorapphy
- Adhesiolysis
- Parathyroidectomy
- Laparoscopic cholecystectomy
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
- Vaporization of urethral tumors
- Release of urethral stricture
- Removal of bladder neck obstruction
- Excision and vaporization of condyloma
- Lesions of external genitalia
- Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation
- Excision or vaporization of condylomata acuminate
- Vaporization of cervical intraepithelial neoplasia
- Cervical conization
- Menorrhagia
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture
- Benign and malignant pulmonary obstruction
- Endoscopic pulmonary applications
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.
The provided text is a 510(k) summary for the Biolitec Ceralas Multiwavelength 980/1470nm Diode Laser System. It outlines the device's intended use, indications, technological characteristics, and a statement of substantial equivalence to predicate devices. However, it does not contain the specific information required to complete most of your request regarding acceptance criteria and a detailed study proving performance.
Here's an analysis based on the available text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific physical parameters with defined thresholds). Instead, it relies on the concept of substantial equivalence to predicate devices.
The "Performance Data" section merely states:
"Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices."
This implies that the device's performance characteristics (e.g., power output stability, wavelength accuracy, safety features) were tested and found to be sufficiently similar to those of the predicate devices. However, the exact metrics and their values are not provided.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | No significant difference compared to cleared predicate devices. | No significant difference compared to cleared predicate devices. |
| (Specific numerical criteria for power, wavelength, safety, etc., are not provided in this document) | (Not specified) | (Not specified) |
Study Details Based on the Provided Text:
Based on the provided 510(k) summary, the device passed its regulatory review by demonstrating substantial equivalence to previously cleared devices. This type of submission generally does not involve a detailed clinical trial with efficacy endpoints in the same way a PMA submission would, nor does it typically involve AI-specific evaluation criteria.
Here's a breakdown of the requested information, indicating where the document lacks specific details:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not describe a specific "test set" in the context of clinical or performance data for the device. The evaluation was based on demonstrating that the new device has "no significant difference" in performance compared to predicate devices, which likely involved engineering and bench testing rather than a large clinical study with a defined test set of imaging data. Therefore, details about data provenance, retrospective/prospective nature, or sample size are not applicable as described in the document.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The document does not describe a "test set" requiring human expert-established ground truth. The comparison is based on the technical specifications and operational characteristics of the laser system relative to its predicates.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the same reasons as above.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a diode laser system for surgical procedures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (a laser system), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical image assessment or AI performance. The "ground truth" for this device would be its adherence to established engineering specifications and safety standards, and its functional similarity to predicate devices, verified through various physical and functional tests (not explicitly detailed in the summary).
-
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the new Ceralas Multiwavelength 980/1470nm Diode Laser System to existing predicate devices (Cynosure Smart Lipo Multiwavelength Laser, Biolitec Ceralas 980nm Diode Laser, and Biolitec Ceralas 1470nm Diode Laser). This regulatory pathway relies on showing that the new device has the same intended use, similar indications for use, similar technological characteristics, and similar principles of operation, and that any minor technological differences do not raise new issues of safety or effectiveness. The "performance data" mentioned refers to testing done to confirm these similarities, not to a clinical study with specific acceptance criteria or ground truth establishment as would be common for AI/diagnostic devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.